Regulatory Affairs Associate

Regulatory Affairs Associate
  • £30,000 - £38,000 per Annum
  • Permanent
  • Cheshire, England, UK Cheshire UK CW7 3RT
Job Ref: J35087
Sector: Science
Sub-sector: Medical Devices
Date Added: 27 July 2020
Regulatory Affairs Associate - Medical Devices

Regulatory Affairs Associate - Medical DevicesDo you have previous experience in medical device regulatory affairs? Are you looking for a role where you can get hands on experience across a wide range of regulatory activities including; premarket, labelling and international registrations?You will:* Create and maintain Regulatory Technical Documentation in compliance with 93/42/EEC (MDD), 2017/745 (MDR) and 21 CFR Part 820.* Manage regulatory submissions in support of new product developments and changes to existing devices for the European and USA markets.* Maintain the Pre-Market and Product Life Cycle processes and SOPs.* Assist in the compilation of the application FMEA in support of Risk Management.* Support the assessment and submission of quality management systems changes to regulatory authorities in Europe and USA, with input from other functions as required.* Act as Pre-Market and Product Life Cycle Subject Matter Expert for the preparation and participation in audits including FDA inspections, Notified Body and customer audits. You have:* An understanding of what documentation is needed to support of Design History File compilation e.g. design inputs/outputs, clinical evaluation reports, risk management* An understanding of labelling and Instructions for Use (IFU) requirements.* ISO 13485 Regulatory Experience * Understanding of the European Medical Devices Regulation (MDR) relevant to this role* Experience in preparation of and obtaining 510(k) clearance would be preferable* Experience in preparation and obtaining Design Dossier approvals would be preferable* Experience in maintaining technical files* Understanding of Risk Management within a Medical Device industryFor more information, please call Laith Mustafa on 0161 868 2231 or email

26/08/2020 10:19:17
GBP 30000 30000
Contact Consultant:
Laith Mustafa

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